Manager, Design Assurance

Job description

Overview Cook Medical is seeking a dedicated and experienced Manager of Design Assurance to lead our Design Assurance team within the Quality Assurance department. This key leadership role involves guiding new product development (NPD) teams, ensuring documentation compliance, and maintaining adherence to Cook Medical’s global quality systems and regulatory standards. Responsibilities: - Lead and manage the Design Assurance Engineering team, including workload management, coaching, and development of team members. - Act as a liaison with company leadership, representing Design Assurance interests. - Provide guidance and mentorship to NPD teams on Cook Medical’s global Design Controls, Process Development, and Risk Management policies and systems. - Participate directly in new product development projects, contributing to design reviews and project deliverables. - Drive the development, deployment, and training of global Design Controls, Process Development, and Risk Management policies. - Maintain a comprehensive understanding of Cook Medical’s design and development policies, standards, and applicable regulations. - Ensure all quality, regulatory, compliance, and product-specific...